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Centogene CentoCancer and CentoCard

Apr 01, 2016

Centogene has launched CentoCancer and CentoCard. CentoCancer is a 31 gene panel that identifies an elevated risk of significant hereditary cancers including breast, ovarian, gastric, colon, endometrial, prostate, pancreatic, renal, liver, and skin cancer. CentoCard is a sample collection system that can be used to extract high-quality DNA to perform any genetic test, the company said. Once samples are dry, they are considered stable and can be mailed through regular post without special declaration.

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Mar 19, 2018

MDNA Life Sciences Mitomic Prostate Test

MDNA Life Sciences has launched the Mitomic Prostate Test Real-Time PCR Kit for research use only in Europe. The liquid biopsy test is designed for the early detection of prostate cancer in advance of biopsy, is independent of PSA and age, and is available for licensee laboratories to conduct in-house validation studies and controlled testing. The assay targets the 3.4-kb mitochondrial DNA deletion and is designed for use on real-time PCR platforms. Each kit contains all necessary reagents to process up to 21 patient samples, MDNA Life Sciences said. The company noted that a CE-IVD version of the kit will be available in July.

Mar 15, 2018

Coriell Life Sciences Bacterial Vaginosis Assay

Coriell Life Sciences launched a solution for the quantitative diagnosis and reporting of bacterial vaginosis. Coriell, together with Quantigen, developed the assay and a reporting algorithm that runs on Thermo Fisher Scientific's real-time PCR-based OpenArray technology. The solution provides affordable and comprehensive sample analysis with rapid turnaround times, allowing Coriell to report which microorganisms are present and at what quantities. The test aids in the differential diagnosis of other vaginal infections that clinically present with the same signs and symptoms as bacterial vaginosis, Coriell said.

Mar 13, 2018

Sekisui/Mesa Biotech Silaris Influenza A&B Test

Sekisui Diagnostics has launched the Silaris Influenza A&B test, a 30-minute PCR-based point-of-care assay developed by Mesa Biotech. The test and testing platform were recently cleared by the US Food and Drug Administration and CLIA-waived under the Mesa branding, the Accula Flu A/Flu B. The test system includes a palm-sized dock and disposable test cassettes. Last year Sekisui Diagnostics inked an exclusive contract with Mesa to distribute the system in the US and Canada.

Mar 09, 2018

PierianDx Clinical Genomics Services

PierianDx this week launched clinical genomics services to complement its Clinical Genomics WorkSpace software product. One component of the services involves preparing labs for precision medicine and expanded molecular testing, which includes planning with the clinical team, molecular tumor board development, physician engagement, and integrating technology into LIMS and EMRs. The other component of the services is focused on the clinical lab such as assay validation, selection, and interpretation. The company said that it also offers turnkey and custom assays performed in a CLIA-certified, CAP-accredited laboratory.

Pacific Biosciences New Polymerase, Software Release

Pacific Biosciences has launched a new polymerase and a new version of its software for its Sequel instrument. The upgrades increase throughput and performance of the Sequel in applications such as de novo assembly, structural variant detection, targeted sequencing, and RNA sequencing. They enable a throughput of 10 gigabases per SMRT cell for long-insert genomic libraries and up to 20 gigabases per SMRT cell for targeted and RNA sequencing applications.

The new release also improves the sensitivity of Iso-Seq, PacBio's RNA sequencing method, while software enhances help simplify the analytics for multiplexed samples, according to the company.

Mar 06, 2018

Baylor Genetics ClariFind

Baylor Genetics has launched ClariFind, a somatic tumor next-generation sequencing test that analyzes alterations in 277 cancer genes for both solid tumors and hematologic malignancies. The test uses molecular indexing prior to PCR and sequencing to enable the detection of low-frequency mutations. The ClariFind report provides annotated genomic findings, any associated targeted therapies and available clinical trials, and an interpretative summary.

Feb 26, 2018

Genomic Health Oncotype DX AR-V7 Nucleus Detect

Genomic Health has launched the Oncotype DX AR-V7 Nucleus Detect Test, a liquid biopsy assay intended to predict treatment response in men with advanced prostate cancer. Developed and performed by circulating tumor cell firm Epic Sciences, the new assay is the first of its kind to be commercially marketed. The test detects the presence of a splice variant of the androgen receptor protein in the nucleus of CTCs using Epic's detection and analysis platform.

The presence of AR-V7 has been shown in research studies to be predictive of whether men will respond to androgen receptor-signaling inhibitors like enzalutamide and abiraterone, or might be better served by chemotherapy.

Optra Health OptraGuru 'Digital Genetic Assistant'

Optra Health has introduced OptraGuru, an Amazon Alexa-compatible "digital genetic assistant" that allows consumers and healthcare professionals alike to verbally query genetic data. Meant to provide context to consumer genetic tests like those from Ancestry.com and 23andMe, OptraGuru puts the Alexa personal digital assistant on the front end of Optra Health's iPhronesis machine-learning platform to help patients, genetic counselors, and bioinformaticians make sense of genetic test results in a conversational manner.

Feb 15, 2018

Twist Bioscience Twist Human Core Exome Kit

Twist Bioscience has commercially launched its Twist Human Core Exome Kit, a comprehensive library preparation and target enrichment kit. It is based on the firm's DNA synthesis technology and includes all the tools needed for library construction, target capture, and enrichment to prepare a sample for sequencing, the firm said. Twist said that as part of the kit, it will offer an option to add IntegraGen’s cloud-based platforms, Mercury and Sirius, for analysis of germline or cancer samples. In addition to the exome kit, Twist also said it has launched a custom panels offering tailored to individual customer requests.

Feb 15, 2018

Omega Bio-Tek Mag-Bind Blood DNA HIV Kit

Omega Bio-Tek announced the launch of its Mag-Bind Blood DNA HV kit, which extracts genomic DNA from large volume blood samples in a fully automated solution. The firm's kit combines extraction chemistry on the Hamilton Microlab STAR liquid platform to provide expedited results for applications including biorepositories, genomics research, and pharmacogenetics that require massive amounts of DNA extraction. The firm believes that the kit will allow researchers to process up to twenty-four 10 milliliters blood samples in 2.5 hours without compromising DNA yield and quality. Omega Bio-tek business director Travis Butts noted that the workflow can perform from volumes as small as 250 microliters to 10 milliliters without additional expensive accessories on the Hamilton platform.

Feb 13, 2018

DNAnexus Clinical Trial Solution

DNAnexus has released Clinical Trial Solution, a cloud-based system that bundles secondary analysis, interpretation, and translational informatics for using next-generation sequencing data in clinical trials. DNAnexus said that its GxP-compliant CTS combines omic information with data from clinical trials to help reduce the time and expense of trial design and drug development.

Feb 13, 2018

SeraCare Seraseq Breast CNV; Lung and Brain CNV Mix

SeraCare Life Sciences launched the Seraseq Breast CNV and Seraseq Lung and Brain CNV Mix, reference materials for analyzing copy number variation. Both have been built with biosynthetic technology that can be easily scalable to incorporate new CNVs over time, and were developed so that clinical labs conducting NGS-based tumor profiling for cancer can better understand and characterize their assays, SeraCare said. They were precisely quantified using highly sensitive digital PCR assays to analyze amplification of EGFR, MET, FGFR3, MYC, ERBB2, and MYCN genes at +3, +6, and +12 copies against a single well-characterized genomic background, the company said.

Feb 12, 2018

Bionano Genomics Direct Label and Stain

Bionano Genomics announced today the global launch of its Direct Label and Stain (DLS), a new chemistry for sequencing motif labeling. The kit is a non-destructive labeing chemistry that will improve the firm's Saphyr genome mapping system. Bionano claims that the DLS will also improve sensitivity for all structural variant calls, yielding detection of heterozygous insertions and deletions as small as 500 bp. The DLS kits will allow high-volume users to map a human genome for $500.